Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2008-04-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Capecitabine
Capecitabine 1000 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
Sunitinib
Sunitinib 37.5 mg daily, continuous dosing
Interventions
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Capecitabine
Capecitabine 1000 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
Sunitinib
Sunitinib 37.5 mg daily, continuous dosing
Eligibility Criteria
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Inclusion Criteria
* Measurable disease as per RECIST. Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
* Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease settings.
Exclusion Criteria
* Brain metastases, spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease.
* Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon (5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1 (tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting
20 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Anjo, Aichi-ken, Japan
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
Pfizer Investigational Site
Okazaki, Aichi-ken, Japan
Pfizer Investigational Site
Toyoake, Aichi-ken, Japan
Pfizer Investigational Site
Chiba, Chiba, Japan
Pfizer Investigational Site
Matsuyama, Ehime, Japan
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan
Pfizer Investigational Site
Kure, Hiroshima, Japan
Pfizer Investigational Site
Morioka, Iwate, Japan
Pfizer Investigational Site
Kyoto, Japan, Japan
Pfizer Investigational Site
Kagoshima, Kagoshima-ken, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Osaka, Osaka, Japan
Pfizer Investigational Site
Sakai, Osaka, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Koto-ku, Tokyo, Japan
Pfizer Investigational Site
Niigata, , Japan
Countries
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Related Links
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Other Identifiers
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A6181163
Identifier Type: -
Identifier Source: org_study_id
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